November 27, 2022

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Top 10 innovative drugs newly launched globally in 2020

Top 10 innovative drugs newly launched globally in 2020

Top 10 innovative drugs newly launched globally in 2020. In 2020, the approval of innovative drugs on a global scale is in a blowout state, and there are many blockbuster anti-tumor innovative drugs, including LOXO-292 (Retevmo), the first specialized 4-line treatment for advanced stomach cancer.

Innovative therapy (Qinlock) for intestinal stromal tumor (GIST), the first targeted therapy for cholangiocarcinoma (Pemigatinib), etc. The rapid development of medical technology has brought new hope to mankind.

 

1.  Tepotinib: The world’s first oral MET inhibitor

  • Generic name: Tepotinib
  • Product name: Teppetko
  • Original researcher: Merck
  • Time to market: March 25, 2020 (Japan MHLW)
  • Indications: For the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) patients with skip mutations in MET exon 14

Top 10 innovative drugs newly launched globally in 2020

On March 25, 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Merck’s Teppetko (tepotinib) for the treatment of unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with skip mutations in MET exon 14 )patient. Tepmetko became the world’s first oral MET inhibitor approved for the treatment of advanced NSCLC patients with MET gene mutations.

As an oral MET kinase inhibitor, Teppetko can potently and highly selectively inhibit oncogenic signals caused by MET gene changes (including METex14 skip changes, MET amplification, and MET protein overexpression), and can improve the carrying of these specific MET changes The prognostic potential of treatment for patients with aggressive tumors. In addition to being used in clinical trials for the treatment of NSCLC patients, Teppetko is also used in phase 2 clinical trials to treat patients with hepatocellular carcinoma. Prior to this, it has obtained breakthrough therapy designation granted by the US FDA.

 

2.  Selpercatinib: The world’s first RET inhibitor

 

  • Generic name: Selpercatinib
  • Commodity name: Retevmo
  • Original researcher: Eli Lilly
  • Time to market: May 8, 2020

Indications: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); adults and pediatric patients ≥12 years old with systemic or recurrent RET mutant medullary thyroid carcinoma (MTC) need systemic therapy; Adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion-positive thyroid cancer, requiring systemic therapy and refractory to radioactive iodine (if appropriate, radioactive iodine is required)

On May 8, 2020, the FDA approved the targeted anticancer drug Retevmo (selpercatinib, 40mg and 80mg capsules) of Loxo Oncology, a subsidiary of Eli Lilly, to treat tumors in specific genes (rearranged genes during transfection, RET gene) patients with 3 types of tumors with genetic alterations (mutations or fusions): non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and other types of thyroid cancer.

Retevmo is a selective RET kinase inhibitor that can block RET kinase and prevent the growth of cancer cells. The approval is based on the overall response rate (ORR) and duration of response (DOR) of the phase I/II clinical study LIBRETTO-001. The data show that the efficacy of Retevmo is significantly better than the currently approved multi-target RET targeted drugs (such as card Botinib, Vandetanib, etc.), and the RET-targeted drug BLU-667 (Pralsetinib) under study is not as effective, or will become the first-line recommendation for RET-positive patients. Previously, the FDA has granted Retevmo Orphan Drug Designation (ODD), Breakthrough Drug Designation (BTD), and priority review qualifications.

As the first therapeutic drug approved specifically for cancer patients carrying RET genetic changes, Retevmo was originally discovered by Loxo Oncology, an American oncology precision drug development company, and Eli Lilly acquired Loxo Oncology for US$8 billion in January 2019. This acquisition is also the largest in a series of transactions that Eli Lilly has made to expand its cancer treatment field.

 

3. Trodelvy: The first antibody conjugate (ADC) drug targeting TROP-2

  • Generic name: sacituzumab govitecan-hziy
  • Commodity name: Trodelvy
  • Original researcher: Immunomedics
  • Time to market: April 22, 2020
  • Indications: Adult patients with metastatic triple negative breast cancer (mTNBC) who have received at least 2 therapies in the past

On April 22, 2020, the FDA accelerated the approval of the antibody-conjugated drug Trodelvy (sacituzumab govitecan-hziy) developed by Immunomedics one and a half months in advance for the treatment of adults with metastatic triple-negative breast cancer who had previously received at least 2 therapies patient. In February this year, the US FDA has granted sacituzumab govitecan breakthrough therapy designation. Trodelvy is the first antibody conjugate drug approved by the FDA for the treatment of triple-negative breast cancer, and the first approved antibody conjugate drug targeting Trop-2 (human trophoblast cell surface antigen 2); previously, there were only 7 The antibody conjugate drug was approved. Domestically, Trodelvy has been approved for clinical use in China.

Trodelvy consists of two parts: the targeted drug part Trop-2 antibody and the chemotherapy part SN-38 (similar to irinotecan). Trop-2 is abundantly expressed on the surface of breast cancer, cervical cancer, colorectal cancer, kidney cancer, liver cancer and other tumor cells. The expression rate of Trop-2 in patients with triple-negative breast cancer is as high as 90%, but the expression is limited in normal tissues. Therefore, Trodelvy can specifically target the Trop-2 monoclonal antibody Sacituzumab to target the active metabolite govitecan (SN-38) of the clinically commonly used chemotherapeutic drug irinotecan to the solid tumor lesions to exert chemical toxicity and killing effect.

 

4. Pemigatinib: The world’s first bile duct cancer targeted drug

  • Generic name: pemigatinib
  • Product name: Pemazyre
  • Original research company: Incyte
  • Time to market: April 17, 2020
  • Indications: Patients with locally advanced or metastatic cholangiocarcinoma carrying fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement previously treated

On April 17, 2020, the FDA accelerated the approval of Incyte’s Pemazyre (pemigatinib) for the treatment of previously treated patients with locally advanced or metastatic cholangiocarcinoma carrying fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement The approval time is one and a half months earlier than the scheduled approval date on May 30. This is also the world’s first targeted therapy for cholangiocarcinoma. Data shows that the objective remission rate of Pemigatinib in patients with FGFR2 fusion/rearrangement exceeds 30%, and the disease control rate More than 80%, and the effect is rapid and lasting.

In terms of domestic listing progress, Cinda Bio has reached a strategic cooperation with Incyte, the research and development pharmaceutical company of pemigatinib, in December 2018, and has the development and commercialization rights of pemigatinib in China (including Hong Kong/Macau and Taiwan). On March 4, 2020, Cinda Biopharmaceuticals has completed the first pemigatinib administration in China, which is an important milestone for pemigatinib to enter the Chinese market.

 

5.  Oxlumo: The first drug to treat PH1

  • Generic name: lumasiran
  • Commodity name: Oxlumo
  • Original researcher: Alnylam Pharmaceutical Company
  • Time to market: November 23, 2020
  • Indications: For the treatment of primary hyperoxaluria type 1 (PH1)

On November 23, 2020, the FDA announced the approval of the RNAi drug Lumasiran (Oxlumo) for the treatment of type 1 primary hyperoxaluria (PH1). This is the first treatment approved by the FDA to treat the rare disease PH1, and it is also the third RNAi treatment approved in the past three years.

PH1 is an extremely rare disease that can affect people of all ages. It is characterized by excessive production of oxalate, which can lead to end-stage renal disease (ESKD) and other systemic complications. Oxlumo is the first drug approved for the treatment of PH1 and the only treatment that has been proven to reduce harmful oxalate levels. The approval of Oxlumo for marketing will have a meaningful clinical impact on PH1 patients. In the United States, Oxlumo has been granted pediatric rare disease status, Orphan Drug Status (ODD), and Breakthrough Drug Status (BTD) for the treatment of PH1 by the FDA. In the European Union, Oxlumo has been granted Orphan Drug Designation (ODD) and Priority Drug Designation (PRIME).

 

6. The first 4-line treatment of advanced gastrointestinal stromal tumor (GIST)

  • Innovative therapy-Qinlock
  • Generic name: ripretinib
  • Product name: Qinlock
  • Original researcher: Deciphera Pharmaceuticals
  • Time to market: May 15, 2020
  • Indications: Patients with advanced gastrointestinal stromal tumor (GIST)

On May 15, 2020, the U.S. Food and Drug Administration announced that it had approved protein kinase inhibitor Qinlock (ripretinib) tablets, becoming the first innovative therapy specifically designed for 4-line treatment of advanced gastrointestinal stromal tumors (GIST). The drug is indicated for adult patients with GIST who have received more than 3 protein kinase inhibitor therapies, including imatinib.

Ripretinib is a tyrosine kinase inhibitor that can inhibit KIT proto-oncogene receptor tyrosine kinase (KIT) and platelet-derived growth factor receptor A (PDGFRA) kinase, including wild-type, primary and secondary Sexual mutation. Ripretinib can also inhibit other kinases in vitro, such as PDGFRB, TIE2, VEGFR2 and BRAF.

In the past 20 years, GIST therapy development has made significant progress, including four FDA-approved targeted therapies-imatinib in 2002, sunitinib in 2006, regofenib in 2013 and this year At the beginning of the year, avaprilini, but there are still some patients who do not respond well to these drugs. The approval of liptinib provides a new treatment option for this part of GIST patients. This approval is mainly based on the data of the Phase III clinical study of INVICTUS. Finally, the results of the study showed that Ripretinib can improve the progression-free survival of patients with fourth-line and above GIST, and the tolerability is generally better.

 

7.  Inmazeb: The first Ebola therapy

  • Generic names: atoltivimab, maftivimab and odesivimab-ebgn
  • Product name: Inmazeb
  • Original researcher: Regenerating Yuan
  • Time to market: October 14, 2020
  • Indications: For the treatment of infections caused by Zaire ebolavirus (Zaire ebolavirus), the drug can be used for adults and children infected, including newborns of mothers who have tested positive for the infection
  • On October 14, 2020, the FDA approved Inmazeb (atoltivimab, maftivimab, odesivimab-ebgn, formerly known as REGN-EB3) for the treatment of infections caused by Zaire ebolavirus (Zaire ebolavirus). The drug can be used Adults and children with infections, including newborns whose mothers have tested positive for infections, are the first drugs approved by the FDA for the treatment of Ebola virus infections.

Inmazeb was developed by Regeneron to target glycoproteins on the surface of the Ebola virus. This glycoprotein binds to receptors on the cell surface, causing the virus to fuse with the host cell membrane, allowing the virus to enter the cell. Inmazeb is a mixture of 3 fully human IgG1 monoclonal antibodies developed using Regeneron’s proprietary VelociSuite® rapid response technology. The 3 antibodies can bind to this glycoprotein at the same time, thereby blocking virus attachment and cell entry. Previously, Inmazeb was granted Orphan Drug Designation in the United States and the European Union, and Breakthrough Drug Designation (BTD) in the United States.

8.  Jelmyto: The first low-grade upper urothelial cancer drug therapy

  • Generic name: mitomycin
  • Product name: Jelmyto
  • Original researcher: UroGen Pharmaceuticals
  • Time to market: April 17, 2020
  • Indications: For the treatment of low-grade upper urothelial carcinoma (UTUC)

On April 17, 2020, the FDA approved the listing of Jelmyto (mitomycin gel) developed by UroGen Pharma for the treatment of low-grade upper urothelial carcinoma (UTUC). Jelmyto is the first and only non-surgical treatment option approved for the treatment of LG-UTUC.

Jelmyto is composed of mitomycin (a chemotherapeutic drug) and sterile gel. It is developed using UroGen’s proprietary slow-release RTGel™ technology. It is an alkylated drug that inhibits the transcription of DNA into RNA and stops protein synthesis. And deprive the proliferation ability of cancer cells. It has been granted Fast Track Qualification, Orphan Drug Qualification, Priority Review Qualification and Breakthrough Therapy Certification granted by the FDA.

 

9. Koselugo: The first drug to treat neurofibromatosis

  • Generic name: selumetinib
  • Commodity name: Koselugo
  • Original researcher: AstraZeneca and MSD
  • Time to market: April 13, 2020
  • Indications: For the treatment of plexiform neurofibroma (PN) that is symptomatic, progressive, and cannot be treated by surgery, neurofibromatosis type 1 (NF1) children aged 2 years and over

On April 13, 2020, the FDA announced that it has approved the listing of Koselugo (selumetinib) jointly developed by AstraZeneca and MSD to treat children with neurofibromatosis (NF1) aged 2 years and over Patients, these patients carry plexiform neurofibromas (PN) that are symptomatic and/or progressive and cannot be treated with surgery.

Koselugo is the world’s first drug for the treatment of neurofibromatosis type 1. If neurofibromatosis type 1 occurs because of N

 

(source:internet, reference only)


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